Drug Enforcement D-0102-2025

Labeling: Not Elsewhere Classified - Wrong NDC number

Status

Ongoing

Classification

Class III

Report Date

December 11, 2024

Termination Date

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Product Information

Product description
Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
Product quantity
4404 packs
Reason for recall
Labeling: Not Elsewhere Classified - Wrong NDC number
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA Nationwide.

Location & Firm

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Address
73 Route 31 N

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0102-2025
Event ID
95767
Recall initiation date
November 14, 2024
Center classification date
December 4, 2024
Code info
Lot#: M408002, Exp 05/31/2026
More code info
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